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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03007212
Other study ID # Hepatocellular Carcinoma
Secondary ID
Status Completed
Phase Phase 4
First received December 24, 2016
Last updated December 29, 2016
Start date September 2014
Est. completion date September 2015

Study information

Verified date December 2016
Source Ain Shams University
Contact n/a
Is FDA regulated No
Health authority Egypt: Institutional Review Board, Ain Shams University
Study type Interventional

Clinical Trial Summary

Portal vein tumor invasion (PVT) is a common complication in HCC. the studyb Aimed to assess the outcomes after TACE in patients with branch PVT regarding Child classification, radiological response and 1 year survival.


Description:

Thirty HCC patients (24 male, 6 females) Child A cirrhotics with branch PVT. Follow up was done at 1, 3, 6 and 12 months after first TACE. All patients underwent laboratory investigations including liver function tests to assess deterioration in liver functions, triphasic spiral CT to assess radiological response according to mRECIST criteria. Survival analysis was performed using Kaplan-Meier estimations.


Recruitment information / eligibility

Status Completed
Enrollment 30
Est. completion date September 2015
Est. primary completion date September 2015
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 65 Years
Eligibility Inclusion Criteria:

- Patients with newly diagnosed HCC,

- Child class A and

- Portal vein branch tumoral thrombus (proved by imaging)

- written informed consent

Exclusion Criteria:

- patients with Child class B and C,

- main Portal vein thrombosis,

- previous management for HCC,

- Arterio-portal shunt

- refused to be enrolled

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment


Intervention

Procedure:
transarterial chemoembolization versus the standard treatment with sorafinib
TACE procedures were performed by the interventional radiologist through femoral artery approach in all patients. Super-selective cannulation of the main feeders was performed using a microcatheter whenever possible. The c-TACE protocol consisted of intra-arterial infusion of cisplatin 50-100 mg mixed with lipiodol ,Just prior to injection, emulsion is prepared by intensive mixing of equal volumes of cytotoxic drug solution and iodized oil using the pumping method with two syringes and a three way stop cock. Injection is guided by fluoroscopy and results in dense accumulation of the emulsion within the tumor vascular bed. Injection of poor iodized oil up to a maximum volume of 10-20 cc is an option and is followed by embolization of feeding arteries by Gelfoam cubes .Endpoints of conventional TACE are complete filling of the tumor vascular bed with iodized oil and stop-flow in subsegmental and segmental feeding arteries..

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Ain Shams University

Outcome

Type Measure Description Time frame Safety issue
Primary changes in Radiological Response in the (CT/ MRI) after the intervention 1 year Yes
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